Devices and methods for surgical suturing

ABSTRACT

An apparatus and a method for surgical suturing with thread management. An illustrative apparatus for tissue suturing includes a cartridge having a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis, a reciprocating needle drive, and an actuator capable of releasably engaging the needle drive to rotate the needle. A method for suturing tissue is provided that includes placing a suturing device having a cartridge containing a suturing needle to span at least one tissue segment, activating an actuator to cause rotational movement of the suturing needle through the at least one tissue segment, and deactivating the actuator to stop an advancing movement of the suturing needle to cause a suturing material to be pulled through the at least one tissue segment forming a stitch.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of priorityto U.S. patent application Ser. No. 15/260,094, filed Sep. 8, 2016,which issued as U.S. Pat. No. 9,649,107, which is a continuation of andclaims the benefit of priority to U.S. patent application Ser. No.13/197,870, filed Aug. 4, 2011, which issued as U.S. Pat. No. 9,445,807,which in turn is a continuation of and claims the benefit of priority toU.S. patent application Ser. No. 11/387,127, filed Mar. 22, 2006, whichis issued as U.S. Pat. No. 8,066,737, which is in turn a divisional ofand claims the benefit of priority of application Ser. No. 11/121,810,filed on May 4, 2005, and which is in turn a divisional of and claimsthe benefit of priority of application Ser. No. 10/127,254, filed onApr. 22, 2002, now U.S. Pat. No. 6,923,819, which in turn claims thebenefit of priority to U.S. Provisional Application Ser. No. 60/298,281,filed on Jun. 14, 2001. Each of the aforementioned patent applicationsis incorporated by reference herein in its entirety for any purposewhatsoever.

FIELD OF THE DISCLOSURE

The present disclosure relates to a surgical device for suturing tissue.More particularly, the present disclosure relates to a suturing devicethat enables the manipulation and control of the suturing needle andsuturing material during operation, and methods for using such a devicefor suturing tissue.

BACKGROUND OF THE DISCLOSURE

Sutures are used in a variety of surgical applications including closingruptured or incised tissue, soft tissue attachment, anastomosis,attachment of grafts, etc. Conventionally, suturing of ruptured orincised tissues, for example, is accomplished by the surgeon passing thesharpened tip of a curved suturing needle with a suture attached to theopposite blunt end of the needle through the incised tissue segments tobe sutured such that the needle tip penetrates the tissue segmentscausing the needle to span the incision. The needle is then pulledthrough the tissue segments manually causing the attached suture tofollow the curved path of the needle. Usually a knot is tied at thetrailing end of the suture to anchor the first stitch. This action isperformed repetitively with application of tension to the needle to pullthe entire suture through the tissue segments through subsequentstitches until the entire incised segments are sutured together with aplurality of stitches.

For example, conventional, open abdominal surgery, including OB-Gynprocedures such as Cesarean delivery, creates a substantial incision(typically eight or more inches in length) in the fascia. In majororthopedic surgery, such as total hip replacement, even longer incisionsin two layers of fascia must be closed. The closure of fascia must bedone carefully at the conclusion of the surgical procedure, prior toskin closure. Closing fascia by hand suturing is a routine, repetitive,and time-consuming procedure. Typical abdominal incisions may take aslong as twenty minutes, while in the case of hip replacement surgery,fascia closure can take even longer. Alternative mechanical suturingdevices, as well as staplers, bone anchors, and suture-based arterialclosure devices have been used as alternatives to hand suturing in otherapplications, since manual suturing is a tedious and the speed of theprocedure is mostly dependent on skill of the surgeon. Moreover, manualsuturing involves the handling and manipulation of a sharp suturingneedle with an instrument such as a needle forceps, which can result inslipping and inadvertent, accidental needle pricks through a surgeon'sor nurse's gloves, posing a potential risk of infection for the surgeon,nurse, staff, and patient. Furthermore, the direct handling of theneedle can cause the needle to become contaminated with pathogenicbacteria that can cause onset of infection at the site of the sutures.There is also a risk of the needle penetrating the bowel and causing aserious, and often fatal infection.

Suturing devices described in the art designed to overcome theselimitations are, however, either unduly complex design and economicallynon-viable or relatively difficult to use and unsuited for precisemanipulation for suturing areas that are not easily accessible. Forexample, the device disclosed in U.S. Pat. No. 4,557,265 has to be heldsideways in relation to the direction of the incision being closed.Another limitation of prior art suturing devices is their inability toprovide positive control over the needle and suture during the suturingprocess. This can result in non-uniform sutures with either overly looseor overly tight stitches, which can cause excessive bleeding and risktearing the repaired tissue in the patient.

A suturing device that maintains a positive control over the suturingneedle and is capable of providing uniform stitches is disclosed in U.S.Pat. Nos. 5,437,681 and 5,540,705. The disclosed device requires a“scissors-like” grip and is operated by the surgeon's thumb thatprovides articulation of the drive mechanism that causes rotation of alinear drive shaft encased in a barrel, which in turn causes a suturingneedle encased in a disposable cartridge mounted at the distal end ofthe barrel to rotate in an advancing motion through the tissue. Thedevice is, however, limited in its efficient operability in thefollowing ways: (1) the rotational direction of the needle and the driveshaft is in a direction that is perpendicular to the device actuatinghandles, thereby rendering the device relatively difficult to manipulateand control, (2) does not allow the user to view the needle and itsprogress through the tissue during the suturing operation, since thebarrel containing the drive shaft leading to the needle cartridge doesnot have an open construction to permit such observation, because theaction of the needle is blocked from user's view by the nature of theinstrument design, thereby making it difficult for the user to positionthe advancing needle with high accuracy along the junction of theincised tissue segments and (3) the rate of needle advancement and,therefore, the size and uniformity of the stitches is essentiallycontrolled by the user by the extent to which the articulation mechanismis depressed, thereby rendering the process of obtaining uniform needlerotation, tissue penetration and suture advancement difficult andentirely dependent on the skill of the user.

SUMMARY OF THE DISCLOSURE

The present disclosure provides a suturing device that closely emulatesor replicates the manual suturing actions carried out by a surgeon. Thesuturing device of the present disclosure provides greater ease of useand allows better visualization for the user during its operation thanpresent mechanical suturing methods, while maintaining control overneedle movement, advancement and suturing thread management during allphases of the suturing process, thereby preventing entanglement of thesuturing thread material during needle movement.

A benefit provided the suturing device of the present disclosure is thatit enables maneuvering a suturing material through a tissue incision ina manner substantially similar to the way a surgeon would do so by hand.In particular, the suturing device first pushes a suturing needle fromthe tail of the needle and drives the point of the needle through thetissue. The device then picks up the point of the needle after it hasbeen driven through the tissue, and pulls the remainder of the suturingneedle and the suture attached to the suturing needle through thetissue. The suturing needle thus consistently follows the arc of its owncurve, which is the preferred method of suturing, in the mostnon-traumatic way of passing a needle through tissue. A benefit providedby the suturing device of the present disclosure is the ability of thesuturing needle to pull the suturing thread entirely through the tissuesegments being closed, following each stitch. The present disclosurealso relates to a suturing device comprising a suturing needle that isprotected by a housing cartridge, whereby the suturing needle is notexposed to or handled directly by the user, thereby precludinginadvertent needle sticks. The configuration of the suturing device ofthe present disclosure also protects against inadvertent penetration ofa bowel by the needle, since the cartridge acts as a shield between thebowel and the needle.

The suturing needle of the present disclosure is configured to fit intoa cartridge, which in turn, is removably attached to the distal end ofthe suturing device. The present disclosure further provides anactuating means and a shaft and drive assembly that provides a torqueingforce to the suturing needle to cause the needle to advance throughtissue during a suturing process without inadvertent retraction.

The suturing device of the present disclosure offers several advantagesover conventional methods used by surgeons for suturing tissue in thatit provides a hand-held suturing instrument of relatively simplemechanical construction and which requires no external motive source.Embodiments of the present disclosure provides relative ease ofoperation for the surgeon with only one hand, thereby enabling thesurgeon to move obstructing tissue, debris and biological fluids fromthe suturing site with a free hand, while eliminating the need forneedle holders, pick-up forceps, and other tools normally required forsuturing by hand. Furthermore, the suturing devices of the presentdisclosure can be configured as to length, tip, needle, suture, andneedle cartridge size for use in conventional open surgery as well as inminimally invasive surgery (MIS) and in “less-invasive” surgery, such asthrough natural orifices or through small incisions. Additionally, thesuturing head can be oriented in any preferred direction and eitherfixed in a particular orientation, or rendered movable in a variety oforientations by an articulation means.

These and other advantages of the present disclosure will be apparentthrough the embodiments described hereinafter. Embodiments of thepresent disclosure accordingly include the features of construction,combination of elements and arrangement of parts that will beexemplified in the following detailed description.

The surgical suturing devices of the present disclosure is configured toprovide a “pistol like” grip for the user that includes a barrelassembly and a handgrip that extends from the proximal end of thebarrel. The barrel assembly has either a linear or non-linearconfiguration, including but not limited to, straight, curved and angledconfigurations. The barrel assembly comprises a plurality of hollowsegments capable of being coupled together by one or more universaljoints that do not require a permanent connection between the segments,enabling segments to be pulled apart individually and separated. Acartridge holder is removably attached to the distal end of the barrelassembly by a plurality of support arms to which is releasably mounted adisposable cartridge that is capable of accommodating a suturing needleand a suturing thread material.

The disposable cartridge has a generally cylindrical housing with anaperture in the sidewall of the housing at the distal or working endthereof. An arcuate suturing needle having a sharp, pointed tip at oneend of the needle is slidably mounted in a circular track at the distalend of the housing and opposite to the location of the aperture. Theneedle is connected to a terminal end of a suturing material or threadwith a suturing thread source, such as for example, a spool assemblythat is contained either entirely within, or remains external thecartridge. The radius of the arc defining the arcuate suturing needle isapproximately equal to the circumference to the cartridge housing at theaperture therein. The needle normally resides in a “home” position inits track such that the gap in the arcuate suturing needle is inalignment with the aperture in the cartridge housing. The sharp, pointedend of the needle is situated on one side and entirely within theconfines of the housing aperture; the pointed end is, therefore, alwaysshielded by the cartridge housing. The blunt end of the suturing needlethat is attached to the suturing thread is located at the opposite sideof the aperture. The sharp, pointed end of the needle is, therefore,wholly contained within the cartridge and does not protrude and beexposed to the user.

In accordance with the present disclosure, the needle may be releasablyengaged by a driving means that is rotatably mounted within the barrelassembly so that the needle can be rotated from its home position byabout 360° about the central vertical axis of the cartridge. Such arotatory action of the needle causes its sharp tip to advance across thecartridge housing so as to span the aperture. Thus, when the device ispositioned such that the incised tissue segments to be sutured aresituated at the housing aperture, the needle penetrates the tissuesegments and spans the incision between them. A continued rotatorymovement of the needle causes it to return it to its original “home”position, and thereby causes the suturing thread attached to the needleto be pulled into and through the tissue in an inward direction on oneside of the tissue incision, and upwards and out through the tissue onthe opposite side of the incision. Thus, the suture follows the curvedpath of the needle to bind the tissues together with a stitch of threadacross the incision in a manner identical to that of a surgeon suturingmanually, wherein the needle is “pushed” from the tail and then “pulled”from the point by the drive mechanism. Preferably, an anchoring means isprovided at the trailing terminal end of the suturing material toprevent the material from being pulled completely through and out of thetissue segments. For example, the anchoring means can be a pre-tied or awelded loop, a knot wherein the suture is simply tied, or adouble-stranded, looped suture is that attached to the suturing needle.

The rotatory movement of the needle within the needle cartridge isaccomplished by a needle driver that may be operated by the user byholding the suturing device with one hand in a pistol-like grip aroundthe handle, and using at least one finger of that hand to activate atriggering lever. The suturing device includes a finger operated triggerlever located proximally to the handle, which when actuated, operates adrive shaft encased within the universal joint barrel assembly through adrive mechanism so as to cause the drive shaft to undergo a rotatorymotion, thereby causing the suturing needle to advance in a circularmotion. Thus, by placement of the device with the needle cartridgeaperture spanning the incised tissue segments and actuating the triggerlever, the suturing device enables the user to lay down a running stitchor interrupted stitch to close the tissue incision in a time efficientmanner.

The needle cartridge of the present disclosure is disposably mounted ona cartridge holder assembly that is removably attached to the distal endof the universal joint barrel assembly. The cartridge holder assembly issupported by a plurality of support arms that extend from the distal endof the universal joint barrel assembly. The minimalized structuraldesign of the support arms enables the user to have a clear,unobstructed view of the suturing needle as it advances through thetissue segments during the course of a suturing operation, therebyenabling precise placement of the suturing device to provide uniformsutures and precluding the risk of tearing tissue by its placement tooclose to the edge of the incision. The suturing devices of thedisclosure is then advanced a short distance along the incision and theaforementioned operation is repeated to produce another stitchcomprising the suturing material. The suturing devices of the disclosurecan either pull the entire suture material through the tissuesautomatically under controlled tension thereby replicating the actionsof a surgeon suturing manually so as to tighten the formed stitcheswithout tearing tissue. Alternatively, the surgeon simply pulls thethread by hand to tighten the stitch placed over the incised tissuesegments by passage of the suturing needle of the suturing devices ofthe disclosure.

The user may continue to manipulate the suturing device, alternatelyadvancing and actuating rotation of the needle about an axis that isgenerally parallel to the direction of advancement to create acontinuous suture which may extend through the entire length of theincision or a series of interrupted stitches. After each individualstitch is laid down, it is tightened by exerting a pull on the suturingmaterial so that the resultant suture is neat and tensioned uniformlyalong the length of the incised tissue segments. Therefore, a tightclosure of the segments is accomplished and bleeding and tearing oftissue are minimized.

As will be described in greater detail below, the needle driver may beoperated by the surgeon holding the instrument with one hand, and usingat least one finger of that hand. The suturing device includes afinger-operated lever that is functionally coupled with internal gearingand forms part of a handgrip that is located at one terminal end of thedevice, that enables the surgeon to efficiently and effectively lay downa running stitch, or a series of interrupted or uninterrupted stitches,to close a tissue incision in a minimum amount of time.

The suturing devices of the present disclosure can additionally includean associated thread management system, which operates in conjunctionwith the needle driver to control or handle the suturing material orthread during rotation of the suturing needle. For example, the threadmanagement roller pushes the thread away from the track so the suturedoes not get pinched by the needle as the needle re-enters the track.Thus, there is minimal probability of the thread becoming tangled orhung up during the suturing operation. The thread management system canalso include a mechanism whereby the suturing material or thread iscontrollably “paid out” during the suturing process.

When using the suturing devices of the present disclosure, no ancillaryinstruments or tools such as needle holders, pick-up forceps or the likeare needed to complete the suture. Also, the suturing device may beconfigured in different ways with respect to length and angle of theuniversal joint barrels, the angle between barrel segments and thenumber and shape of the support arms. The size of the needle, needlecartridge, cartridge aperture and aperture position may also be variedfor use in open surgery to perform procedures such as closing of thefascia, skin closure, soft tissue attachment, anastomosis, fixation ofmesh, grafts and other artificial materials. The suturing devices of thepresent disclosure may also be designed with a very small working end ortip at the end of a long rigid shaft or a flexible shaft that can beoriented in any preferred direction so that the instrument may be usedfor MIS, such as suturing in the course of endoscopic surgery, includinglaparoscopy, thoracoscopy and arthroscopy, as well as less-invasivesurgical procedures.

In addition to offering all of the advantages discussed above, thesuturing devices of the present disclosure are relatively simple andcost efficient to manufacture. Therefore, the suturing devices shouldfind widespread suturing applications that include single stitches orcontinuous stitches, e.g. spiral, mattress, purse string, etc., that arerequired to close tissue incisions, attach grafts, or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the present disclosure.

FIG. 1 shows a pictorial view of the suturing device of the presentdisclosure including the main components of a cartridge, a cartridgeholder assembly, drive shaft segments, a universal coupling jointassembly and a sleeve, an actuator handle with an actuating trigger.

FIG. 2 shows a sectional view of the shaft-universal joint assemblyattached to one embodiment of the suturing device functional endcomprising the pusher, cartridge assembly and cartridge operable by aside drive mechanism.

FIG. 3A shows a segmented sectional view of suturing device functionalend comprising a universal joint assembly without and with the universaljoint sleeve. FIG. 3B shows an identical view with the universal jointsleeve.

FIGS. 4A, 4B and 4C show enlarged views of a single universal joint,joint coupler and a pair of coupled universal joints respectively.

FIG. 5 shows an expanded view of the universal joint sleeve configuredat a 30° angle.

FIG. 6 shows a detailed view of one embodiment of a cartridge mountassembly comprising pair of supporting arms and a shaft segment.

FIGS. 7A and 7B show two different views of one embodiment of the needlecartridge.

FIGS. 8A and 8B show two embodiments of the curved suturing needle withsuture material ports that are operable by a side drive mechanism.

FIG. 9 shows an expanded view of the thread management roller housed inthe cartridge.

FIG. 10 shows an expanded view of the “anti-rotate” pin housed in thecartridge assembly.

FIG. 11A shows an expanded view of the pawl. FIG. 11B shows an expandedview of the pusher comprising a cartridge holder support arm with thepawl in place.

FIG. 12 shows a cut-away segment view showing interaction points of asuturing needle with a cartridge holder and support arm components.

FIG. 13 shows a segmented view of the relative configuration of asuturing needle with respect to the cartridge holder.

FIG. 14 shows a segmented sectional view of the functional end of asecond embodiment of the suturing device operable by a rear drivemechanism comprising a shaft segment, the pusher, cartridge holder andcartridge (shown sectionally in FIGS. 15-19).

FIG. 15A shows a perspective view of a pusher with a cartridge holderassembly comprising an attached cartridge with a suture threadingmechanism for restraining a suture material.

FIG. 15B shows a pusher comprising the cartridge holder assembly and acut-away section of a cartridge comprising the curved suture needle thatis operable by a rear drive mechanism.

FIG. 16 shows an expanded view of a curved suturing needle with suturematerial port that is operable by a rear drive mechanism.

FIGS. 17A and 17B show front and rear views of the cartridge.

FIG. 18 shows a cut-away sectional top view of a pusher comprising acartridge holder assembly with a locking gate.

FIGS. 19A, 19B and 19C shows the operation of the pusher arm in acartridge assembly operating in a rear drive mode. The pusher armtraverses radially by opening the gate (FIG. 19A), which springs to theclosed position (FIGS. 19B and 19C) after its passage.

FIGS. 20A, 20B and 20C show a three-dimensional, a sectional and across-sectional view, respectively, of a ratchet assembly of the presentdisclosure that is driven by a drive shaft and activates a pusher armupon device actuation.

While the above-identified drawings set forth preferred embodiments ofthe present disclosure, other embodiments of the present disclosure arealso contemplated, as noted in the discussion. This disclosure presentsillustrative embodiments of the present disclosure by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and sprit of the principles of the present disclosure.

DETAILED DESCRIPTION

The suturing device of the present disclosure is shown generally at 1 inFIG. 1. Referring to FIG. 1, the illustrated suturing device 1 of thepresent disclosure can be used to produce a continuous or interruptedstitch or suture so as to enable closure of the segments of an incisedtissue. The suturing device 1 includes an actuator handle 12 comprisinga proximal end 6 and a distal end 8 that allows the device 1 to be heldin a pistol grip by the user, and a trigger lever 16. The actuatorhandle 12 is attached to a pusher 9 at the distal end of handle 12. Thepusher 9 comprises a of shaft barrel assembly 10 comprising a pluralityof shaft segments capable of housing a drive shaft (not shown) thatextend outwardly from a housing 14 at the distal end 8 of the actuatorhandle 12. The shaft barrel assembly 10 is comprised of at least twosegments with symmetric coupling assemblies that are coupled to oneanother with a universal joint coupler (not shown). The coupled assemblyis enclosed within a universal joint sleeve 18 such that the universaljoint barrel is configured at an angle of about 30° from horizontal. Theshaft segment 10 distal from the actuator handle 12 is attachedremovably to a support arm assembly 22 that is comprised of a pair of“skeletalized” arms extending along mutually divergent axes so as toprovide an opening 23 to view the device working end 19 during itsoperation. The working end 19 of the suturing device 1 comprises acartridge holder assembly 20 that is removably attached to the supportarm assembly 22, to which the needle cartridge 24 is disposablyattached.

FIGS. 2-13 provide detailed views of the various components of oneembodiment of the suturing device 1 and the manner in which thecomponents are configured in the final assembled device to enable itsoperation via a “side-drive” mechanism in the manner described.

FIG. 2 shows the working end 19 of the suturing device 1 including theuniversal joint coupling sleeve 18, the universal joint segment distalto the actuator handle (not shown) a “pusher” 9 comprising a support armassembly 22 and a cartridge holder assembly 20 with an attacheddisposable needle cartridge 24, and a universal joint assembly (hidden)encased in a joint sleeve 18.

FIGS. 3A and 3B provide detailed segmental views of the suturing deviceworking-end 19 showing the disposable needle cartridge 24 in adisengaged mode and a curved suturing needle 26 separated from theneedle cartridge 24 to illustrate the relative configuration of thesesegments with respect to the cartridge holder assembly 20, the pusher 9comprising the support arm assembly 22 and the universal joint segments.FIG. 3A shows the coupled junction mode involving coupling of the shaftsegments 10 comprising a universal joint coupler (hidden), while FIG. 3Bshows the coupled shaft segments 10 encased in a coupling joint sleeveor “sweep” 18 that aligns the cartridge mount 20 from the stem to theactuator handle at about 30°. The sweep 18 can be either pre-configuredto provide a pre-determined fixed angle for the cartridge mount(relative to actuator handle), or can be configured to be adjustable toprovide the user with the ability to vary the cartridge mount angle to asetting optimal for a particular procedure.

FIGS. 4A-C show expanded views of the hollow universal joint segment andthe manner in which two identical segments are coupled. As shown in FIG.4A, the shaft segment 10 comprises a hollow cylindrical barrel 28 withtwo open ends, and two pairs of arcuate slots 32 and 34 at one end,wherein one pair of arcuate slots is narrower than the other.Additionally, the joint segment contains a plurality of circularopenings 36 located on the cylinder surface to accommodate acorresponding number of restraining pins in the universal joint sleeve(“sweep”) 18 that are identical in diameter. Two shaft segments 10having identical arcuate slot configurations 32 and 34 may be coupledtogether using a universal joint coupler 38 (FIG. 4B) comprising aplurality of pins 40 such that the coupler engages the pair of narrowslots 32 of the conjoining joint segments 32, thereby providing ajunction connecting the two shaft segments 10 that is non-rigid (FIG.4C). The angle between coupled segments 10 can, therefore, be varied.The coupled segments 10 provide a conduit for passage of a drive shaft(not shown) for activating needle movement.

FIG. 5 shows a “transparent” view of the universal joint sleeve or“sweep” 18, which comprises of a hollow tubular segment with two openends 28 whose tubular axis bends over a predetermined angle. The sleeve18 additionally comprises a plurality of slots 30 positioned along itsside wall that are capable of engaging the corresponding circularopenings 36 on the shaft segments 10 that are positioned appropriatelyby means of restraining bolts on pins 38. The sweep 18 therefore,enables the angle of the coupled shaft segments 10 to be “locked” in apreferred angle. The sleeve 18 can be configured to have either a fixedangle, or to have the capability to provide the user the ability toadjust the angle to a preferred setting. In one embodiment, the sweep 18provides an angle of about 30° from horizontal. The angle for thecoupled universal joint segments 10 determined by the sweep in turn,determines the angle of the cartridge holder assembly 20 which isattached to the shaft segment 10 at the distal end 8 of the actuatorhandle 12 (via the support arm assembly 22). The cartridge holder anglerelative to actuator handle 12, in turn, determines the accessibility ofthe suturing device 1 at the site of the suturing procedure which iscritical, depending on whether it is open and planar, or non-planar andnarrow.

FIG. 6 shows a detailed view of the pusher 9 that includes a cartridgeholder assembly 20 that is attached to a support arm assembly comprisinga pair of “skeletalized” support arms 22 which in turn, is attached tothe terminal end of shaft segment 10. The open configuration of the“skeletalized” support arms 22 that are minimal in bulk is an essentialfeature of suturing device 1 that provides a relatively wide opening 23that allows the user to directly view the aperture in the needlecartridge and cartridge (not shown) holder assembly 20, the incision inthe tissue and needle advancement through the incised tissue segmentsduring operation of suturing device 1. Although the embodiment shown inFIG. 6 has a plurality of support arms 22, other variants include asupport arm assembly comprising a single support arm as illustrated inFIG. 11B. The improved viewing ability offered by the shape andconfiguration of the support arm assembly 22 enables precise deviceplacement over the incision, and uniform advancement of the suturingdevice after every stitch to provide a uniform and symmetric suture,thereby minimizing the risk of tearing tissue and bleeding due to astitch being positioned too close to the edge of the incised tissue. Thecartridge holder assembly 20 is composed of a sterilizable medical gradematerial which can either be a metallic material such as stainless steelto enable its reuse subsequent to sterilization following a prior use,or a sterilizable medical grade plastic material, in which case, it maydiscarded and disposed after a single use. The cartridge holder assembly20 has a cylindrical configuration with a distal edge 40 and a proximaledge 42 with respect to the device actuator handle (not shown), with anaperture 45 that corresponds in dimension and location to coincide witha substantially similar aperture located in the disposable needlecartridge. The cartridge holder assembly 20 additionally comprises aplurality of slots 44 located along on the distal edge 40 in that arelocated diametrically opposite to one another, and are capable ofengaging the same plurality of retaining clips correspondingly locatedin the needle cartridge housing (not shown). The cartridge holderassembly 20 further comprises a cylindrical slot 46 located on thedistal edge 40 that is capable of engaging a positioning pin ofidentical diameter correspondingly located on the needle cartridgehousing (not shown). The proximal edge 42 of the cartridge holderassembly is attached to the shaft segment 10 distal to the actuatorhandle 12 via a support assembly comprising at least one “skeletalized”support arm 22.

FIGS. 7A and 7B show two different views of an embodiment of adisposable suturing needle cartridge 24 in accordance with the presentdisclosure, which is preferably offered in a sterilized sealed package.The cartridge 24 comprises a circular housing 48 that may be formed of asuitable rigid medical grade sterilizable metal or plastic material. Thehousing may be releasably retained by the cartridge holder assembly 20at the distal end 19 of suturing device 1 (working end) by known means,such as a plurality of clips 50 (shown in FIG. 7A) located along on theedge of an inner lip 52 in diametrically opposite positions that arecapable of engaging the same plurality of slots correspondingly locatedin the cartridge holder assembly 20. The cartridge 24 further comprisesa cylindrical positioning pin 54 located on the edge of the inner lip 52that is capable of engaging a cylindrical slot of identical diametercorrespondingly located on the cartridge holder assembly 20. While theretaining clips 50 when engaged enable the cartridge to be retained bythe cartridge holder assembly 20, the positioning pin 54 when engaged inthe slot causes the aperture in the cartridge 24 to be aligned with thecorresponding aperture in the cartridge holder assembly 20. The needlecartridge 24 further comprises an aperture 56 and a circular groove or“track” 58 that is inscribed in the inside surface of the housing 48,which lies in a plane that is perpendicular to the longitudinal axis ofboth the housing 48 and that of the suturing device 1. As shown in FIG.7A, the cartridge-housing aperture 56 interrupts the track 58. Anarcuate surgical suturing needle 26 composed of medical grade stainlesssteel or similar material is slidably positioned in the track 58.

FIGS. 8A and 8B show embodiments of the arcuate suturing needle 26 ofthe present disclosure. In one embodiment (FIG. 8A), the needle 26 isformed as a circular split ring with a gap 59, a sharp, pointed end 60,and a blunt end 62. The needle 26 further comprises an opening toaccommodate the leading end of the suturing material. In one embodiment,the opening is the form of an eye 64 through which the leading end ofthe suturing material may be passed through for attaching it to theneedle 26. In the illustrated needle (FIG. 8A), the eye 64 is locatedadjacent to the blunt end 62. The eye 64 however, can be positionedanywhere along the arc or the needle 26 between its apex 61 and theblunt end 62. In a preferred embodiment (FIG. 8B), the needle 26comprises an opening in the form of a cylindrical bore 66 alignedaxially with respect to the needle 26, located at the blunt end 62 (FIG.8B). The leading end of the suturing material is inserted into the boreand restrained by mechanically crimping. To enable the needle 26 topenetrate tissue to the required depth, the needle preferably has anarcuate extent between about 280° and about 330°, and more preferably,greater than about 270°. The needle 26 comprises two symmetric notches68 along the radially inner edge (“inner notches”) that are positionedproximally to the sharp, pointed end 60 and the blunt end 62 of theneedle 26. The notches 68 are located directly opposite to each other,each having a perpendicular (about 90°) segment and an angular segmentthat makes an angle of about 60° with the perpendicular segment. Theinner notches 68 are engaged by the drive mechanism in the cartridgeholder assembly 20 and enable the needle 26 to undergo a rotatorymovement upon actuation of the drive mechanism, thereby causing it topenetrate into and advance through tissue. A similar triangular notch 70is located on the radially outer edge (“outer notch”) of the needleproximally to the inner notch 68 closer to the sharp, pointed end 60.The outer notch 70 engages with an “anti-rotate” pin located in thecartridge holder assembly 20, whereby rotation of the needle 26 in adirection opposite to the advancing direction or “needle backing-up” isprevented. The positive engagement of the needle outer notch 70 duringoperation of the suturing device 1, and thereby precludes needle 26 fromstraying out of sequence during the suturing process.

The width of the aperture 56 in the cartridge housing 48 is comparableto and corresponds with the width of the gap in the needle 26 so thatwhen the needle 26 is in the “home” position (as shown in FIG. 7A) itdoes not project materially into the aperture 56. Such an alignmentcauses the needle to reside entirely within the cartridge holder 20,thereby preventing inadvertent contact of the sharp pointed end 60 withthe user's fingers during handling of the disposable needle cartridge 24for its placement on the cartridge holder 20 or its disposal after use,and while operating the suturing device 1. Such protection of the needle26 in the suturing device of the present disclosure prevents accidental“needle-pricks” from occurring, thereby substantially reducing the riskof infection caused by pathogenic bacteria or viruses that maycontaminate the needle during or after its use prior to its disposal.The needle 26 may be rotated in its curved track 58 about thelongitudinal axis of the suturing device 1 to advance the pointed needletip 60 so that the needle first spans the aperture and then return toits original or home position. Since the suturing material is attachedto the needle 26, it follows the path of the needle 26. The terminal endof the suturing material may contain a knot or button to prevent it frompulling through the sutured tissue during placement of the first stitch.The suturing material or thread may be stored in an enclosed packagingeither externally or internally with respect to the needle cartridgehousing 48, and be pulled out of that packaging prior to placement ofthe first stitch in the suturing process. In a preferred embodiment, thecartridge housing 48 comprise the suturing needle 26 attached to theterminal end suturing material or thread, and an appropriate length ofsuturing material are all packaged in a terminally sterilizable medicalpackaging material.

FIG. 9 shows a thread management roller 72 of the present disclosurewhich acts to push the thread away from the track so the suture does notget pinched by the needle as the needle re-enters the track. The threadmanagement roller 72 comprises a spring operated stop pin 74 thatmaintains a positive pressure against the suturing material or thread,thereby preventively retaining the suturing material in the threadretaining slot of the suturing needle, while keeping the thread out ofthe needle track to preclude the thread from jamming needle movement.The stop pin 74, therefore, prevents jamming of needle movement by aninadvertent entry of the suturing material into the needle slot withinthe needle cartridge 24 when the material is pulled forward by theadvancing movement of the needle 26.

FIG. 10 shows an expanded view of the anti-rotate pin 75 that is capableof engaging the outer notch of the needle 26 to prevent rotation of theneedle 26 and prevent “needle backing-up” and thereby precluding theneedle 26 from straying out of sequence.

FIG. 11B shows an expanded view of a pusher assembly comprising pusher76 and a pawl 78 (FIG. 11A) located at its tip, which resides in acorresponding slot in the support arm 22 of the pusher assembly, and isconnected the support arm 22 by a pivot pin 80. The needle 26 is drivenin a circular path by a rigid arm (“pusher”) that extends from a hublocated in the center of the suturing device 1. The pawl 78 at the tipof the pusher 76 is capable of interfitting with the wedge shapednotches located along the radially inner edge of the needle. The pusher76 is activated by the user upon operation of the actuator trigger inthe actuator handle 12, and is capable of sweeping back and forth in anarc spanning about 280°. The outer surface of the pusher 76 is shaped toaccommodate a C-shaped spring (not shown) that causes the wedge-shapedpawl 78 to push up against the needle 26 and thereby remain in intimatecontact. The advancing movement of needle 26 during its operation causesthe triangular slots 68 along the radially inner edge of needle 26 alignwith the wedge-shaped pawl 78 in the pusher 76, thereby causing the pawl78 to engage the slots 68 due to a positive pressure exerted on the pinby the C-shaped spring, and to “lock” into the slots 68. The rotatoryadvancing movement of the needle 26 is therefore controlled to occursequentially through about 280° each time it is actuated.

FIG. 12 shows a cut-away segmental view of the needle 26 in the homeposition inside the cartridge (not shown) with respect to the stemcartridge holder assembly (not shown). The relative locations of thepawl 78 that engages the notches 68 in the radially inner edge of theneedle 26, the thread management roller 72 and the anti-rotate pin 75that engages the notch 70 in the radially outer edge of the needle 26are shown in FIG. 12.

FIG. 13 shows a cut-away view of the needle 26 within the cartridge (notshown) in the “home” position, the alignment of the needle aperture withthe corresponding aperture in the needle cartridge holder 20, therelative position of the needle 26 and cartridge holder 20 and aperturelocation with respect to the coupled shaft segments 10 that are coupledby universal joint coupler 38 and maintained at a fixed angle by therestraining coupling sleeve or “sweep” (not shown).

FIGS. 14-20 show detailed component views of a preferred embodiment ofthe suturing device of the present disclosure and the manner in whichthe components are configured to enable its operation as describedherein.

FIG. 14 shows the working end of a preferred embodiment of the suturingdevice of the present disclosure, comprising a “pusher” 9 having asupport arm assembly 80 and a cartridge holder assembly 82 with theattached disposable needle cartridge 84. The “pusher” 9 is connected tothe drive mechanism via shaft segment 86 that is coupled via a universaljoint coupling comprising a universal joint assembly encased in a sleeve(not shown) to a second shaft segment distal to the actuator handle 12.The shaft segment 86 is attached to the universal joint assembly by pinsthat engage slots 88 with corresponding slots in the coupling assembly.

FIG. 15A shows segmental views of the pusher assembly comprising aneedle cartridge 84 engaged with cartridge holder assembly 82. Thecartridge 84 attaches to cartridge holder assembly 82 via a mountingclip 90 located at the apex of the arc of the cartridge holder assembly82 that slidably “locks” into position with a complementary slot 92located correspondingly on the apex of cartridge 84. Both cartridgeholder assembly 82 and cartridge 84 comprise an aperture 96 that are ofsimilar dimension, and aligned with one another in the “locked”position. The cartridge 84 further comprises a suturing materialmanagement cleat 98 which is capable of restrictibly maintainingsuturing material 100 in a manner so as to preclude its entanglement asit travels into cartridge 84 during operation of the suturing device.

FIG. 15B shows a cut-away view of the pusher assembly exposing asuturing needle 102 residing within cartridge 84 (not shown) in the“home” position, wherein the alignment of the needle aperturecorresponds with apertures of both needle cartridge holder assembly 82,and the cartridge 84. The needle 102 is placed in the “home” position byengaging cartridge 84 with cartridge holder assembly 82 in a “lockedposition, whereupon it is restrained by clip 90 in a manner causing itto be engaged with notches located along the radially rear edge of theneedle (not shown) that is proximal to cartridge holder assembly 82 bycorrespondingly located pins in a drive arm located in the cartridgeholder assembly 82 that is part of a “rear-drive” needle rotation driveoperating mechanism.

FIG. 16 shows a preferred embodiment of the curved suturing needle 102of the disclosure. The needle 102 is formed as a circular split ringwith an aperture (or gap) 106, as sharp, pointed end 108 and theopposite end 110. A cylindrical bore 112 aligned axially with respect tothe needle, located at the blunted 110. The leading end of the suturingmaterial is inserted into the bore and restrained by mechanicallycrimping. Alternatively, the opening for accommodating the suturematerial can be in the form of an “eye” wherein the leading end of thesuturing material may be passed through for attaching it to the needle102. To enable the needle 102 to penetrate tissue to the required depth,the needle 102 preferably has an arcuate extent between about 280° andabout 330°, and more preferably, greater than about 270°. Needle 26comprises two symmetric notches (“rear notches”) 114 along the radiallyrear edge, i.e. the edge proximal to the cartridge holder 82, that arepositioned proximally to the sharp pointed end 108 and the oppositeblunt end 110 of the needle 102, respectively. The rear notches 114 arelocated directly opposite to one another, each having a perpendicular(about) 90° segment and an angular segment that makes an angle of about60° with the perpendicular segment. The rear notches 114 are engaged bythe drive mechanism in the cartridge holder assembly and enable theneedle to undergo a rotational movement upon actuation of the drivemechanism, thereby causing it to penetrate and advance through tissue. Asimilar triangular notch 116 is located on the radially outer edge(“outer notch”) of the needle proximally to the rear notch 114 that iscloser to the sharp, pointed end 108. The outer notch 116 engages withan “anti-rotate” pin located in the cartridge holder assembly, wherebyrotation of the needle in a direction opposite to the advancingdirection or “needle backing-up” is prevented. The positive engagementof the needle outer notch 116 during operation, therefore, precludes theneedle from straying out of sequence during the suturing process.

FIGS. 17A and 17B show the outer and inner views, respectively, of thecartridge 84. The outer surface of the cartridge 84 (FIG. 17A) comprisesa suturing material management cleat 98 which is capable of restrictiblymaintaining the suturing material in a manner to preclude itsentanglement. The cartridge 84 further comprises a slot 92 located atthe apex of an actuate edge that slidably engages a complementarilylocated pin on the cartridge holder assembly to “lock” it in position.The inner surface of the cartridge 84 comprises a track 118 that permitsthe suturing needle (not shown) housed within to travel in a rotationalmotion from its “home position” so as to span aperture 106 duringoperation. A slot 120 located radially on the inner surface of cartridge84 engages with a complementarily located pin on the cartridge holderassembly such that when the pin is engaged slidably in slot 120, theneedle is constrained to remain in and move along track 118.

FIG. 18 shows a top sectional view of a preferred embodiment of a“pusher” 9 comprising a cartridge holder assembly 82 and support arms22. The cartridge holder assembly 82 comprises a plurality of mountingclips 122 that are capable of receiving the cartridge 84, and a mountingclip 90 at the apex of the radial edge and slidably engaging acomplementarily located slot in the cartridge that engages cartridgeholder assembly 82, thereby causing the drive mechanism in the assembly82 to engage the suturing needle housed within the cartridge. Thecartridge holder assembly 82 further comprises a gate assembly 124 thatprevents needle 102 from leaving its track and falling out into the backof the cartridge holder assembly 82. The gate assembly 124 is maintainedin a closed “home” position by a torque force exerted by a spring 126 towhich it is coupled via a pin 128, thereby restricts lateral movement ofneedle 102. The gate assembly 124 opens during each actuation of thesuturing device to permit a circular movement of the drive mechanismthat engages needle 102, and closes to the home position immediatelyafter passage of the drive mechanism to preclude lateral movement anddislocation of needle 102 within cartridge holder assembly 82.

FIGS. 19A, 19B and 19C show serial views of the “rear-drive” needleoperating drive mechanism operating within the cartridge holder 82 ofthe pusher assembly (not shown). The “rear-drive” mechanism comprises adriver arm 130 connected to a drive shaft 132 that is capable ofcircular motion so as to “sweep” along the circular inner edge of thecartridge holder 82 comprising the gate assembly 124. Actuation of thedevice causes the drive shaft 132 to rotate in a clockwise direction,thereby causing driver arm 130 to move circularly from its “home” restposition and move up to and the past gate assembly 124, causing it toopen in the process (FIGS. 19A and 19B). The driver arm 130 continues tomove circularly until it comes to rest once again in the “home” position(FIG. 19C). The gate assembly 124 returns to its closed home positionafter passage of the driver arm 130, thereby allowing driver arm 130 to“drive” needle 102 in a circular motion, while preventing the needle 102from becoming dislocated from track 118. Thus, each time suturing device1 is actuated, driver arm 130 moves past the gate assembly 124, openingthe gate assembly 124 in the process. Since the gate assembly 124 movesback into its closed “home” position after passage of the driver arm130, it precludes lateral movement of the needle 102, thereby preventingneedle 102 from jamming due to misalignment during operation.

FIGS. 20A, 20B and 20C show the dimensional, sectional and transparentsectional views, respectively, of a ratchet assembly 134 of the presentdisclosure that is part of the drive mechanism for the suturing device1. FIG. 20A shows the ratchet assembly 134 comprises a ratchet ring 136with a predominantly arcuate outer surface segment 137 having aplurality of teeth 138, and an arcuate flat segment 140 that having aplanar surface. The ratchet ring 136 includes a central circular bore(not shown) that fits slidably over and attaches immovably to a piniongear 142 comprising a shaft 144. The ratchet ring 136 further comprisesa plurality of wedged surfaces 139 a and 139 b that are proximal to theflat segment 140. The ratchet assembly 134 is mounted on a base 146comprising a housing 148 that accommodates a pawl (hidden) that isactivated by a coil spring (not shown) and a shuttle 150, that isattached to a support bracket 152 by a plurality of screws 153. FIG. 20Bshows a detailed sectional view of the ratchet ring 136 comprising acircular bore 154 that is capable of slidably receiving and attaching tothe shaft 144 of the pinion gear 142 (not shown). The ratchet ring 136is mounted on the base 146 so that the teeth 138 of the ratchet ring 136are interactively meshed with the pawl 156. The pawl 156 is activated bya coil spring (not shown) that exerts a positive pressure on the pawl156 causing it to remain in intimate contact with the teeth 138 of theratchet ring 136. The shuttle 150 is attached to the base so that itallows the ratchet ring 136 to rotate in a unidirectional (such as, forexample, clockwise) until the circular movement is arrested by contactbetween the shuttle 150 and a first wedge 139 a in the ratchet ring 136.Movement of the shuttle 150 after contacting the first wedge 139 apermits the ratchet ring 136 to rotate in a direction opposite to theinitial direction of rotation (such as, for example, counter-clockwise)until the movement is stopped by contact of shuttle 150 with the secondwedge 139 b. FIG. 20C shows a transparent sectional view of the ratchetring 136 where the teeth 138 of the ratchet ring 136 are enmeshed withthe pawl 156, which is maintained in intimate contact with the teeth 138by a positive pressure exerted by the action of a coil spring 158.

The ratchet assembly 134 of the present disclosure may be suitablylocated within the handle 12 of the suturing device 1. In a preferredembodiment, the ratchet assembly 134 is located at the distal end 8 ofthe actuator handle 12, whereby the shaft 144 of the ratchet assembly134 is a part of a shaft segment 10 that is terminally attached to atriggering mechanism of the suturing device 1. Activation of thesuturing device 1 by actuating the triggering mechanism (not shown) viathe trigger 16 in the actuator handle 12 causes the shaft 144 and theattached ratchet ring 136 and the pinion gear 142 in the ratchetmechanism 134 to rotate unidirectionally, the pinion gear 142 to drivethe shaft segment 10 coupled to the driver arm 130 of the rear-drivemechanism in the pusher 9, which in turn, causes the engaged needle 102to rotate in the same direction to effectuate penetration of incisedtissue by the needle 102 pulling the suturing thread material with it.The rotation of the shaft 144 is arrested after travelling about 280°upon contact by a first wedge 139 a with the shuttle 150, which in turn,terminates the first actuation step. The shuttle 150 then permits theshaft 144 with the attached ratchet ring 136 and the pinion gear 142 torotate through an equal distance in the opposite direction until themovement is stopped once again by the contact by the shuttle 150 withthe second wedge 139 b. An advantage offered by the ratchet mechanism134 of the present disclosure is that the actuation step of the suturingdevice 1 is pre-determined, that is, the ratchet assembly 134 preventsthe user from performing an incomplete actuating event that could resultin an improper or incomplete suture by causing the needle 102 to snag inthe tissue. Furthermore, the ratchet assembly 134 is capable ofoperation by the trigger 16 in a manner independent of its orientationwith respect to the trigger 16 and actuator handle 12, such as forexample, when it is oriented in an upside down or sidewaysconfiguration.

The actuating means of the suturing device 1 of the present disclosuremay comprise of a triggering mechanism that is known in the art, such asfor example, the triggering mechanisms disclosed in U.S. Pat. Nos.6,053,908 and 5,344,061, both of which are hereby incorporated byreference. Alternatively, the actuating means can be either a manuallyoperable button or switch, or a mechanically operable by an automatedelectrical or a fuel driven device, such as for example, an electrical,electromagnetic or pneumatic motor powered by electrical,electromagnetic, compressed air, compressed gas, hydraulic, vacuum orhydrocarbon fuels.

To commence suturing, any embodiment of the suturing device 1 of thepresent disclosure is placed at the site of the wound or tissue incisionsuch that it spans the wound or the two tissue segments created by theincision, following which it is actuated by operation of the actuatortrigger 16 on the actuator handle 12. The detailed operation of thesuturing device 1 of the present disclosure is described with referenceto the preferred embodiment, and is equally applicable to all otherembodiments of the disclosure described and contemplated herein. Thepawl in the pusher mechanism of the suturing device 1 engages the notch114 located radially rear edge proximal to the blunt end or “tail” ofthe suturing needle 102 and pushes the needle in a circular path in anarc spanning about 280°. The sharp, pointed end 108 of the needle 102crosses the aperture 96 defined by the cartridge 84 and the cartridgeholder 82, and penetrates the first tissue segment located within theaperture 96, traverses the tissue segment to penetrate the second tissuesegment, and re-enters the device on the opposite side of the aperture96. The pusher 9 then returns to its original location, whereupon thepawl engages the notch located radially rear edge 114 proximal to thesharp, pointed end of the needle 102. The needle 102 with the attachedsuturing material or thread is consequently pulled in a circular paththrough an arc of about 280°. The blunt end 110 of the needle 102 andthe suturing material therefore, pass through the tissue segments andacross the wound or incision so as to span the wound or incision. Theneedle 102 comes to rest at its original “home” position within thetrack in cartridge holder 82, having advanced through a completecircular arc of about 360°. The needle 102 including the sharp, pointedend 102 remains entirely contained within the cartridge 84. The suturingmaterial or thread may then be cut and secured by an appropriate method,such as for example, by tying, or additional stitches may be placedalong the entire wound or incision by repeating the aforementionedprocess. Every stitch, whether a single, interrupted stitch, or one of aseries of continuous, running stitches may be placed in like manner. Thesuturing device 1 of the present disclosure, therefore, may be used toinsert either a single stitch, or to insert a suture comprising aplurality of continuous stitches as a replacement method for a moretedious and time-consuming manual suturing process.

While a suturing device 1 having the separable suture cartridge 84containing the suturing needle 102, a pusher 9 comprising a cartridgeholder 82 with the support arms 80, a drive shaft assembly comprisingthe driver arm 130, and an actuator handle 12 comprising the actuatingtrigger 16 and drive mechanism has been described, the entire suturingdevice 1 can be designed as a single unit which may be either reusableor disposed in its entirety after a single use.

It will thus be seen that the examples set forth above among those madeapparent from the preceding description are efficiently attained in thesuturing device of the present disclosure. Also, since certain changesmay be made in the above description without departing from the scope ofthe disclosure, it is intended that all matter contained in the abovedescription or shown in the accompanying drawings shall be interpretedas illustrative, and not in a limiting sense.

What is claimed is:
 1. A surgical suturing device including an arcuatesuturing needle and an actuator attached to a reciprocating needle driveconfigured to advance the arcuate suturing needle along a circularneedle track and across a gap in the needle track through tissue to besutured, the arcuate suturing needle including: a) an arcuate body witha pointed end and a second end, the arcuate body defining a centralarcuate axis along the centerline of the arcuate body, the centralarcuate axis defining a circular plane, the arcuate body having an upperarcuate face and a lower arcuate face, the upper arcuate face and lowerarcuate face meeting at the circular plane; b) a gap defined between thepointed end and the second end; c) a first notch defined in the needlelocated along the upper arcuate face of the arcuate body toward thepointed end, the first notch being defined by at least one surface, theat least one surface of the first notch extending laterally across theneedle from a radially inner region of the needle to a radially outerregion of the needle, the first notch being configured to receive adrive pawl of the reciprocating needle drive; and d) a second notchdefined in the needle located along the upper arcuate face of thearcuate body toward the second end of the needle, the second notch beingdefined by at least one surface, the at least one surface of the secondnotch extending laterally across the needle from a radially inner regionof the needle to a radially outer region of the needle, the second notchalso being configured to receive the drive pawl of the reciprocatingneedle drive.
 2. The surgical suturing device of claim 1, wherein thearcuate suturing needle further includes a piece of suturing material,wherein an opening defined in the needle proximate the second end of theneedle retains an end of the suturing material.
 3. The surgical suturingdevice of claim 1, wherein the first notch and the second notch eachdefine a first surface substantially perpendicular to the arcuate axisand a second surface that defines an angle of about sixty degrees withrespect to the first surface.
 4. The surgical suturing device of claim1, wherein the first surface of the first notch and the first surface ofthe second notch both face toward the second end of the needle.
 5. Thesurgical suturing device of claim 1, further comprising a needlecartridge for holding the needle.
 6. The surgical suturing device ofclaim 1, wherein the actuator includes a handle.
 7. The surgicalsuturing device of claim 1, wherein the needle is disposed in aremovable cartridge that is removably attached to a cartridge holderassembly of the surgical suturing device.
 8. The surgical suturingdevice of claim 7, wherein the cartridge holder assembly is configuredto releasably engage the cartridge and to bring the needle rotationdrive into operational contact with the arcuate suturing needle.
 9. Thesurgical suturing device of claim 7, wherein suturing material is alsodisposed within the cartridge.
 10. The surgical suturing device of claim9, wherein the cartridge further includes a suturing material dispensercontaining the suturing material.
 11. The suturing device of claim 10,wherein the cartridge further includes a thread management system formanaging movement of suturing material attached to the arcuate suturingneedle.
 12. The surgical suturing device of claim 7, wherein thecartridge further includes at least one mounting clip wherein thecartridge is releasably engaged with the cartridge holder assemblyhaving the needle rotation drive.
 13. The surgical suturing device ofclaim 1 wherein the needle covers an arc greater than about 280° andless than about 330°, and further wherein the needle further defines anaperture adjacent to the second end of the needle for engaging thesuturing material.
 14. The surgical suturing device of claim 1, whereinthe needle is disposed within a disposable portion of the suturingdevice.
 15. The surgical suturing device of claim 14, wherein thedisposable portion of the suturing device includes a removablecartridge.
 16. The suturing device of claim 1, wherein a center of thecircular needle track that coincides with the central arcuate axis isunobstructed by the needle drive.
 17. The suturing device of claim 1,wherein the device is configured to push suture away from the circularneedle track so the suture does not get pinched by the needle as theneedle re-enters the circular needle track after passing across the gap.18. The suturing device of claim 17, wherein the device defines a windownear a distal end of the device that facilitates viewing of the arcuatesuturing needle as the arcuate suturing needle is advanced along theneedle track.
 19. The suturing device of claim 17, wherein the actuatoris electrically automated.
 20. The suturing device of claim 17, whereinthe arcuate suturing needle further includes an outer notch defined in aradially outer edge of the arcuate body.
 21. The suturing device ofclaim 20, wherein the outer notch is disposed between the first notchand the second notch along a length of the arcuate body.